Swedish Life Science Investor Meeting 2024

Technical Readiness Levels

Below you can read about the definitions of the different readiness levels for Pharma & Biotech, Medtech & Diagnostics and Digital Health.

TRL 4 Validation of the technology in the laboratory

Preclinical R&D. Optimization of candidates and in vivo demonstration of activity and efficacy. Identification and integration of critical technologies (animal models, biomarkers, assays, etc.) in continued characterization of and development of potential candidates.
Initiation of GMP process development and manufacturing of non-GMP material and drug formulations.
Evaluation of safety, pharmacodynamics and pharmacokinetic properties.
Formulation of a Target Product Profile initiated

TRL 5 Validation of technology in a relevant environment

Further characterization of candidate, i.e. absorption, distribution, metabolism and elimination.
Manufacturing process established amenable to large scale GMP manufacturing and consistent with the intended use of the drug. Development of in process controls and relevant analytical assays.
Continued development of animal models for efficacy and dose-ranging studies. Selection of candidate drug. GLP safety studies for IND submission and Phase 1

TRL 6 Demonstration of technology in relevant environment

Clinical development. GMP production, IND submission and Phase I clinical evaluation performed proceeding to Phase II.
Additional safety evaluations conducted necessary to support further development

TRL 7 Technology prototype demonstrated in an operational environment

Phase II clinical study is completed. Manufacturing process scale-up and process validation initiated and stability testing ongoing.
Continued safety studies to support further clinical testing.
TPP refined when necessary. Phase III clinical plans defined and approved by regulatory authorities.

TRL 8 Technology system completed and qualified through test and demonstration

Manufacturing processes validated.
Pivotal clinical Phase III testing and safety studies completed.
NDA or BLA prepared and submitted. Approved by appropriate regulatory authorities.

TRL 9 Technology system in its final form ready for full (commercial) deployment in relevant operating environment

TRL 4 Validation of the technology in the laboratory

Preclinical R&D. Laboratory testing of critical components and processes.
Proof of concept of device demonstrated in relevant laboratory and animal models.

TRL 5 Validation of technology in a relevant environment

Further development of device candidates and system solutions. Validation of system components and processes in relevant laboratory environment.
Classification of device by appropriate regulatory body and when appropriate an Investigational Device Exemption (IDE) prepared and submitted for review.

TRL 6 Demonstration of technology in relevant environment

System/device prototype demonstrated in an operational environment. Clinical testing to demonstrate safety may be required.
Depending on the classification of the device Premarket approval or Premarket notification (510(K)) apply.

TRL 7 Technology prototype demonstrated in an operational environment

Clinical safety and effectiveness trials conducted using a fully integrated prototype version of the medical device in an operational environment.
Data evaluated to support further development.
The final product design validated and final prototype and/or device intended for commercial use produced and tested.

TRL 8 Technology system completed and qualified through test and demonstration

TRL 9 Technology system in its final form ready for full (commercial) deployment in relevant operating environment

TRL 4 Validation of the technology in the laboratory

System components integrated and tested regarding preliminary efficiency and reliability.
Software architecture and other system components development to address reliability, scalability, operability, security etc.

TRL 5 Validation of technology in a relevant environment

System component architecture established.
System tested in relevant testing environment as expected in the operational environment.
Verification, validation and accreditation when appropriate initiated.

TRL 6 Demonstration of technology in relevant environment

Representative model or prototype system demonstrated in relevant live or simulated environment. System component releases are “beta” versions and configuration controlled.
Support structure in development and verification and validation and when needed accreditation for safety reasons in progress.

TRL 7 Technology prototype demonstrated in an operational environment

System tested in an operational environment. Support structure in place and System component releases in distinct versions.
Verification, validation and when appropriate accreditation completed.

TRL 8 Technology system completed and qualified through test and demonstration

Development completed. System demonstrated to work under real life conditions.
Testing of design specifications. System component releases are production versions.
Support structure in place to resolve technical issues.

TRL 9 Technology system in its final form ready for full (commercial) deployment in relevant operating environment